Study

Overview

Official Title: A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

Study Type:

Interventional

Study Phase:

Phase 2

Estimated Enrollment:

300

Study Start Date:

June 2023

Estimated Study Completion Date:

December 2025

Estimated Primary Completion Date:

December 2025

Eligibility

Ages Eligible for Study:

18 years to 80 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)

Exclusion Criteria:

History of liver disease other than NASH
History or evidence of cirrhosis
History of pancreatitis
History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality
Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack

Locations

United States Toll Free Number 1-800-770-4674

Guaynabo, 00970
Rio Piedras, 00935
San Juan, 00907
San Juan, 00909
Chandler, Arizona, 85224
Peoria, Arizona, 85381
Tucson, Arizona, 85712
Tucson, Arizona, 85715
Camarillo, California, 93012
Gardena, California, 90247
Huntington Park, California, 90255
La Mesa, California, 91942
Lancaster, California, 93534
Los Angeles, California, 90057
Panorama City, California, 91402
Pasadena, California, 91105
Sacramento, California, 95821
Bradenton, Florida, 34208
Cutler Bay, Florida, 33189
Fort Myers, Florida, 33912
Hallandale Beach, Florida, 33009
Hialeah, Florida, 33012
Hialeah, Florida, 33016
Lakewood Ranch, Florida, 34211
Miami, Florida, 33173
Miami Lakes, Florida, 33016-1518
Dalton, Georgia, 30720
Chicago, Illinois, 60621
Iowa City, Iowa, 52242
Las Vegas, Nevada, 89101
East Syracuse, New York, 13057
New York, New York, 10075
Cincinnati, Ohio, 45242
East Greenwich, Rhode Island, 02818
Brownsville, Texas, 78520
Dallas, Texas, 75230
Houston, Texas, 77079
San Antonio, Texas, 78215
San Antonio, Texas, 78229
West Jordan, Utah, 84088
Roanoke, Virginia, 24014

Canada Study Coordinator 4035925049

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-6024-013

Study Detail

A Clinical Study of Efinopegdutide in Participants with Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)